NCT05865457招募中不适用
Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Signs
研究概览
简要总结
The goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are:
- Is BUFY02 non-inferior to TRB02 in terms of signs of DED?
- Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED?
Participants will be asked to:
- Visit the trial site at 4 different timepoints
- Use the allocated study treatment everyday until the end of the study (during 3 months)
- Be examined by the investigator
- Complete several questionnaires
- Return unused study treatment.
Researchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;
- •At least one eye with Oxford score ≥ 4 and ≤ 9;
- •At least one objective sign of tear deficiency (in at least one eligible eye);
- •Having a health insurance.
排除标准
- •Wear of contact lenses starting within the last 2 months;
- •Best-corrected visual acuity (BCVA) > 1.00;
- •Severe DED with one of the listed conditions:
- •Severe blepharitis;
- •Seasonal allergy;
- •Any issues of the ocular surface not related to DED;
- •History of ocular trauma, infection or inflammation not related to DED;
- •History of ocular surgery, including laser surgery;
- •Unstable glaucoma;
- •Use of artificial tears with preservative within the last 2 weeks;
- •Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:
- •Known hypersensitivity to any constituent of the study treatments;
- •Pregnancy or breastfeeding;
- •Participation in another clinical study within the last 90 days;
- •Legally restricted autonomy, freedom of decision and action.
研究组 & 干预措施
BUFY02
Experimental
0.3% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.45 mL
干预措施: BUFY02 eye drops in single-dose containers (Device)
TRB02
Active Comparator
0.3% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.45 mL
干预措施: TRB02 eye drops in single-dose containers (Device)
结局指标
主要结局
Signs
时间窗: Day 28
Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome)
次要结局
- Symptoms(Day 28)
研究者
研究点 (6)
Loading locations...
相似试验
招募中
不适用
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye DiseaseDry Eye DiseaseNCT05865379TRB Chemedica International SA80
已完成
2 期
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCTChronic Myeloid LeukemiaAcute Myelogenous LeukemiaMyelodysplasiaAcute Lymphocytic LeukemiaNon-Hodgkin's LymphomaLymphoproliferative DiseaseAdvanced Myeloproliferative DiseaseMultiple MyelomaSevere Aplastic AnemiaNCT00516152University of California, San Francisco36
已完成
2 期
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's DiseaseParkinson DiseaseNCT06055985UCB Biopharma SRL207
已完成
2 期
BTRX-246040 Study in Participants With Parkinson's Disease With Motor FluctuationsMotor DisorderParkinson DiseaseNCT03608371BlackThorn Therapeutics, Inc.24
终止
2 期
Study on the Effect of Ibrutinib on High Risk Smoldering Multiple Myeloma PatientsHigh Risk Smoldering Multiple MyelomaNCT02943473Icahn School of Medicine at Mount Sinai9